Services Offered

  • Expertise in Chemical and Pharmaceutical Development
    • Evaluation and optimization of synthetic routes to drug candidates
    • Adaptation of discovery chemistry routes (if possible) for scale-up and use as enabling routes
    • Chemical process development and optimization at all stages of development; preparation for registration and validation campaigns
    • Creation and execution of fit for purpose R&D, production and cGMP manufacturing strategies and plans
    • Design of syntheses of stable isotope and radiolabeled molecules for support of in vivo PK/ADME studies
    • Physicochemical characterization of APIs
    • Solid state chemistry – polymorphism, salt screening and selection; form selection
    • Sourcing of raw materials, starting materials, excipients and standards
    • Drug product development and manufacturing - selection of appropriate strategy based on molecular properties, selection and leadership of appropriate vendors, oversight of preformulation, formulation development and drug product CTM manufacturing, collaboration with DMPK/tox colleagues in translational evaluation of preclinical and clincal prototypes and formulations
  • Vendor Selection, Engagement and Management
    • API, drug product, analytical, custom synthesis and production, import/export, QA and regulatory support
    • Creation of requests for proposal
    • Definition of scope of work, deliverables and timelines
    • Facilitation of performance and completion of work
    • Technology transfer  - assembly of tech transfer packages, performance of tech transfer to and between vendors and organizations
    • Excellent vendor network
  • Problem Solving
    • Troubleshooting of chemical process development and API manufacture, drug product process development and manufacture, analytical method development
    • Leadership of expert teams in the solution of complex technical problems
    • Broad, multidisciplinary consultant network
  • Assistance with Strategy and Management of Drug Development Programs
    • Coordination of CMC activities
    • Liaison between technical functions, regulatory, QA;  Effective, clear communication across disciplines
  • Technical and Regulatory Documentation
    • Drafting, review and editing of development reports
    • Authorship, review and editing of CMC regulatory documents, including INDs, NDAs, amendments, biowaivers
  • Regulatory/QA
    • Interpretation and application of FDA and ICH guidances pertaining to CMC development activities
    • Practical experience in quality audits and mock PAIs in the US, EU, India and Japan